POAGまたは高眼圧症に対するクリタンテック テンフェノPF®またはエリプティック テンフェノPF®プラス ギャプ テンフェノPF®の有効性の比較研究。 (PRO-122)

実験的：アーム 1;ドルゾラミド - チモロール - ブリモニジンおよびラタノプロスト;クリタンテック テンフェノ PF® および ガープ テンフェノ PF®

研究期間中、24 時間ごとに 21:30 時間 (± 15 分) に Gaap Manyo® (ラタノプロスト 0.005%; 防腐剤を含まない) 点眼液を適用します (総曝露量: 90 日間)。 Gaap Teeno® の点眼を開始してから 1 か月後、Krytantek Manyo® (ドルゾラミド 2%、チモロール 0.5%、およびブリモニジン 0.2%; 防腐剤を含まない) 点眼液を 12 時間ごとに 9:00 および 21:00 時間 (± 10分) (合計暴露: 60 日)。

薬：ドルゾラミド-チモロール-ブリモニジンおよびラタノプロスト

30 日間、24 時間ごとに Gaap Manyo PF® を塗布し、60 日間、12 時間ごとに Krytantek Manyo PF® を同時に塗布します。 合計介入時間: 90 日。

他の名前：

• PRO-122
• クリタンテック テンフェノ PF®
• ガープ テンテオ PF®

実験的：アーム 2;ドルゾラミド - チモロールおよびラタノプロスト;エリプティック テンフェノ PF® および ガープ テンフェノ PF®

研究期間中、24 時間ごとに 21:30 時間 (± 15 分) に Gaap Manyo® (ラタノプロスト 0.005%; 防腐剤を含まない) 点眼液を適用します (総曝露量: 90 日間)。 Gaap Manyo® 点眼開始から 1 か月後、Eliptic Manyo® (ドルゾラミド 2% およびチモロール 0.5%; 防腐剤を含まない) 点眼液を 12 時間ごとに 9:00 および 21:00 (± 10 分) に追加します (合計暴露：60日）。

薬：ドルゾラミド - チモロールおよびラタノプロスト

30 日間、24 時間ごとに Gaap Manyo PF® を適用し、60 日間、12 時間ごとに Eliptic Manyo PF® を同時に適用します。 合計介入時間: 90 日。

他の名前：

• ガープ テンテオ PF®
• エリプティック テンフェノ PF®

Change in Intraocular Pressure (IOP)

Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated at 9:00 and at 11:00 hrs. (± 30 minutes). Both measurements and their average will be registered. Normal values are considered between 10 and 21 mmHg. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.

眼の快適性指数の変化

眼の快適性指数 (OCI) アンケートは、0 から 100 までのスケールでのドライアイ症状の発生率と重症度による忍容性の評価に使用されます。 スコアが高いほど、結果が悪いことを意味します。

Best Corrected Visual Acuity (BCVA)

Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.

BCVA was compared between groups and between visits. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.

Optic Nerve Cup/Disc Ratio (Baseline Vist vs Final Visit)

Both clinical and imaging evaluation will be performed. For clinical evaluation, after the application of a topical ophthalmic mydriatic (tropicamide 0.8% / phenylephrine 5%), indirect ophthalmoscopy will be performed through the aid of a fundus lens in a slit lamp. For imaging, optic coherence tomography (OCT) will be used. Assessed and reported only for the basal visit and final visit.

Mean Value in Nerve Fibers and Ganglion Cell Thickness

Spectral domain OCT is a non invasive tool that will be used to evaluate quantitatively the thickness of retinal nerve fibers and ganglion cell layers. The mean observed in the nerve fibers and ganglion cell thickness was calculated. This was assessed and reported only for the basal and final visit.

Optic Nerve Image

Through a fundus camera a photograph will be taken to obtain a faithful record of any possible changes to the optic nerve head characteristics. Its classification as "small", "medium" or "large" relied on the expertise of the PI, the percentage of cases in each classification ("small", "medium" or "large") was reported. Assessed and reported only for the basal visit and final visit.

Central Corneal Thickness (CCT)

Measured through ultrasonic pachymetry, three assessments will be performed, these and its average will be recorded. Assessed and reported for the basal visit and final visit.

Change in Visual Fields

Visual fields will be assessed using standard automated SITA (Swedish Interactive Thresholding Algorithm) white-on-white perimetry performed with a Humphrey perimeter. To be considered reliable, fixation losses, false positives, and false negatives must be less than 20%.

The mean deviation (MD) was recorded, which is a measure of overall field loss. The standard deviation of the pattern was also recorded, which is a measure of focal loss or variability within the field. A higher score is a worse result.

The theoretical value or reported range for the average deviation is from +2.00 to -35 dB.

Change in Ocular Surface Integrity (Chemosis)

By means of a slit lamp chemosis will be evaluated. Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent. The number and percentage of participants in each category was reported.

Number of Adverse Events

Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.

Change in Ocular Surface Integrity (Conjunctival Hyperemia)

By means of a slit lamp conjunctival hyperemia will be evaluated. Conjunctival hyperemia will be graded according to Efron's scale (5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4)).

Percentage of Cases Who Reached a Specific IOP Decrease in mmHg

Percentage of cases who reached a reduction in IOP within the following ranges: ≤12, ≤13, ≤14, ≤15, or ≤18 mmHg. Each range is a classification and the percentage is calculated with the counts of cases in each classification. PIO was assessed in the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, and was reported for the first follow-up visit, second follow-up visit, and final visit.

The initial objective of the study was to report the percentage of patients who achieved a specific reduction in intraocular pressure (IOP). However, because the study ended early, the number of participants was limited, and both eyes per patient were included, we chose to present the full dataset in order to provide a more comprehensive report.

Percentage of Cases Who Reached a Specific IOP Decrease in Percentage

Cases who demonstrated decrease in IOP within the following percentage ranges: ≥ 20%, ≥ 25%, ≥ 30%, y ≥ 35%. Each range is a classification and the percentage is calculated with the counts of cases in each classification. PIO was assessed in the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, and was reported for the first follow-up visit, second follow-up visit, and final visit.